MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIVATOR; SNARE, FLEXIBLE

Model Number M00562341

Device Problems Failure to Deliver Energy (1211); Entrapment of Device (1212); Failure to Cut (2587)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/24/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a captivator medium hexagonal stiff snare was to be used during a colonoscopy procedure performed on (b)(6) 2021.It was reported that during the procedure and inside the patient, the physician was using the hex snare with cautery to remove a large polyp.When they tried to cut the polyp, there was no cauterization.The snare could not be removed immediately because it was stuck on the polyp.They cut the wire to remove the snare from the patient.Reportedly, the snare was securely attached to the active cord and no issues were noted with the cautery pin and device.The procedure was completed with a different captivator snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable/good.

Manufacturer Narrative

Problem code a150208 captures the reportable event of snare loop entrapment.Problem code a050702 captures the reportable event of loop failure to cut block h10: investigation results a captivator medium hexagonal stiff snare was received for analysis.Visual inspection of the returned device revealed that the working length and wire were cut off.No other problems were noted.The reported complaints of failure to deliver energy, loop failure to cut and loop entrapment of device or device component were not confirmed since the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.Additionally, the device was returned with the sheath and wire cut off making it impossible to perform any test.Upon device analysis it was noted that the working length and wire were cut off which matched with the reported complaint that stated that the device was cut.The user may have applied excessive force trying to remove the device from the polyp resulting in the device damaged.The product record review confirmed that this is not a new failure type and the risk is anticipated.There is no evidence of a manufacturing issue, design or user issue which could have caused the complaint.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected.This code was selected as the problem cannot be confirmed based on device condition that made it impossible to perform any tests.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

Event Description

It was reported to boston scientific corporation that a captivator medium hexagonal stiff snare was to be used during a colonoscopy procedure performed on (b)(4) 2021.It was reported that during the procedure and inside the patient, the physician was using the hex snare with cautery to remove a large polyp.When they tried to cut the polyp, there was no cauterization.The snare could not be removed immediately because it was stuck on the polyp.They cut the wire to remove the snare from the patient.Reportedly, the snare was securely attached to the active cord and no issues were noted with the cautery pin and device.The procedure was completed with a different captivator snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable/good.

• Brand Name: CAPTIVATOR
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12031537
• MDR Text Key: 257175925
• Report Number: 3005099803-2021-02887
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729019350
• UDI-Public: 08714729019350
• Combination Product (y/n): N
• PMA/PMN Number: K131700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2024
• Device Model Number: M00562341
• Device Catalogue Number: 6234
• Device Lot Number: 0027069005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Date Manufacturer Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention